Gilead Sciences IncPositive Phase 3 results for once-weekly oral HIV regimen islatravir/lenacapavir, showing non-inferior viral suppression and higher satisfaction vs daily Biktarvy.
Gilead Sciences and Merck announced that the investigational once-weekly oral single-tablet HIV treatment regimen of islatravir 2 mg and lenacapavir 300 mg maintained virological suppression in adults with HIV who switched from daily antiretroviral therapy, according to Week 48 results from the Phase 3 ISLEND-1 and ISLEND-2 trials. In ISLEND-1, no participants who switched to the once-weekly regimen had HIV-1 RNA of 50 copies per milliliter or more at Week 48, compared to 0.3 percent of those who remained on BIKTARVY, while in ISLEND-2 the rates were 0.3 percent for the once-weekly regimen versus 1.3 percent for standard-of-care daily treatments. The safety profile of the once-weekly combination was generally similar to the comparator regimens, with no new safety concerns identified, and participants who switched reported higher treatment satisfaction and lower treatment burden. The data will be presented at the 26th International AIDS Conference and will form the basis of regulatory submissions, with the potential to make this the first once-weekly oral HIV treatment option.
Gilead Sciences IncPositive Phase 3 results for once-weekly oral HIV regimen islatravir/lenacapavir, showing non-inferior viral suppression and higher satisfaction vs daily Biktarvy.
Merck & Company IncPositive Phase 3 results for once-weekly oral HIV regimen islatravir/lenacapavir, co-developed with Gilead, showing non-inferior viral suppression and higher satisfaction.
Merck KGaA